Cleaning Validation Engineer - Katalyst Healthcares & Life Sciences

• Lead development and maintenance of cleaning validation strategy compliant with US FDA requirements.

• Create cleaning cycle development programs for a variety of equipment including process vessels, clean-in place systems, packaging equipment, parts washers, and production facilities.

• Evaluate manufacturing process documents and equipment cleaning procedures for validation purposes.

• Lead investigation and troubleshooting problems which occur during cleaning.

• Responsible for planning and execution of onsite cleaning validation programs.

• Prepare and review completed and executed validation packages by compiling and analyzing validation data for submittal for review and approval.

• Lead resolution of cleaning deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval.

• Collaborate with other departments to define protocol contents and actions.

• Develop and author change controls for cleaning process or equipment changes.

• Write and execute IQ/OQ/PQ and cycle development protocols including final reports.

• Maintain an up-to-date knowledge of validation requirements, practices, and procedures.

• Write validation plans and risk assessments related to specific projects and facilities.

• Facilitate the development of user requirement specifications and operational SOPs for equipment.

• Lead cleaning studies, spray coverage testing, cleaning verification swabbing, and risk sampling.

• Responsible for identifying appropriate facility cleaning/sanitizing agents; participates in cleaning/sanitizing effectiveness studies.

• Develop, review, and revise standard operating procedures and guidelines for product and equipment cleaning.

• Other duties as assigned.

Requirements:

• Bachelor's Degree or equivalent in a scientific/pharmaceutical area

• 5+ years of cleaning validation or engineering work in GMP and FDA regulated environment.

• Ability to independently generate protocols and reports for evaluation experiments.

• Advanced knowledge of various analytical equipment and techniques utilized in an analytical laboratory.

• Understanding of regulatory requirements related to cleaning validation and cleaning equipment/CIP design.

• Experience in risk management and client service/project management.

• Demonstrated ability to work both independently and in a team environment.

• Familiarity with production equipment and processing technologies.

• Proficient in Microsoft Office programs (Word, Excel, Outlook, CAD) and CRM software.

• Travel up to 10%.

• Knowledge of EU and other global requirements & standards.

• Demonstrated Analytical and Problem-Solving Skills.

• Ability to elicit cooperation from a wide variety of sources, including upper management, customers, suppliers, board, and other departments.

• Excellent written and oral communication skills.

• Ability to lift to 25 pounds.

• Ability to work in a dynamic environment with shift priorities.